Indian Pharma Companies Get 207 ANDA Approvals From US FDA During First Half Of 2019

Mumbai, 25 July 2019:

The Indian research-based pharmaceutical companies have improved their presence in international market during the last couple of years with investments in research and development (R&D) activities. This can be seen from rising Abbreviated New Drug Application (ANDA) approvals from US FDA. Indian pharma companies and their subsidiaries grabbed a total of 207 final ANDA approvals out of the total 476 ANDA approvals during the first half ended June 2019 by US FDA or over 43 per cent of total approvals. Similarly, US FDA offered 102 tentative approvals of which Indian companies received 55 tentative approvals.

Sun Pharmaceutical Industries and Taro Pharmaceuticals received the highest number of final ANDA approvals during the first half ended June 2019. It received a total of 28 ANDA approvals. Zydus Pharma got 23 approvals and was followed by Alembic Pharmaceuticals 14, while Cipla and Aurobindo received 12 approvals each. Lupin and Accord Healthcare, subsidiary of Intas Pharma grabbed 10 each approvals. This was followed by Glenmark Pharma (8), Torrent Pharma and Dr Reddy’s Laboratories (7 each), and Ajanta Pharma, Cadila Healthcare and Micro Laboratories (6 each).

Among the total 55 tentative approvals by Indian companies during the first half ended June 2019, Alkem Laboratories, Glenmark Pharma and MSN Labs received 5 tentative approvals each. Torrent Pharma received 6 tentative approvals and Zydus Pharma and Sunn Pharma got 4 approvals each.

US FDA approved a total of 813 final ANDAs and 194 tentative approvals during the year 2018 and Indian companies had received total 290 final and 77 tentative approvals.

Sun Pharmaceutical Industries R&D expenditure declined 7.4 per cent to Rs. 1,913 crore during 2018-19 from Rs. 2,067 crore in the previous year. The company has 453 ANDA approved by US FDA while awaiting approval for 118 ANDAs, including 13 tentative approvals. It filed 9 ANDAs during the fourth quarter ended March 2019 and received 12 approvals. Additionally, the pipeline includes 51 approved NDAs while 8 NDAs awaits approvals. For the full year ended March 2019, Sun Pharma’s consolidated net sales increased by 10.1 per cent to Rs. 28,686 crore from Rs. 26,066 crore in the previous year. Its other operating income declined by 10.4 per cent to Rs. 380 crore from Rs. 424 crore while other income increased by 22.2 per cent to Rs.1,025 crore from Rs. 839 crore.

Aurobindo Pharma’s R&D expenditure reached at Rs. 872 crore. It filed 62 ANDAs in 2018-19 and received approval for 48 ANDAs. Cumulative basis the company filed 541 ANDAs and received total 403 ANDA approvals, including 26 tentative approvals. It launched 50 net products in the markets. During the fourth quarter March 2019, Acrotech Priopharma LLC, a wholly owned subsidiary of Aurobindo Pharma Inc, which in turn is a wholly owned subsidiary of the company has completed the acquisitions of 7 branded oncology injectable products from Spectrum Pharmaceuticals Inc. Further, it completed acquisition of Apotex in five European countries.

For the full year ended March 2019, Aurobindo’s consolidated net sales increased by 18.4 per cent to Rs. 19,226 crore from Rs. 16,233 crore in the previous year. Its other operating income went up to Rs. 338 crore from Rs. 267 crore and other income grew to Rs. 116 crore from Rs. 102 crore. Its net profit declined by2.4 per cent to Rs. 2,365 crore from Rs. 2,423 crore. EBITDA improved by 4.3 per cent to Rs. 3,952 crore from Rs. 3,789 crore and EBITDA margins worked out to 20.2 per cent.

Alkem Laboratories’ R&D expenditure went up to Rs. 462.2 crore during the year ended March 2019 from Rs. 364.6 crore in the previous year. Alkem's consolidated net sales increased by 14.9 per cent to Rs. 7,357 crore from Rs. 6,401 crore in the previous year. Its net profit increased by 21.3 per cent to Rs.774 crore from Rs. 638 crore. EPS worked out to Rs. 63.61 as against Rs. 52.77 in the last period. Its domestic sales increased by 8.6 per cent to Rs. 4,874 crore and that in international markets grew by 31.2 per cent to Rs. 2,392 crore. Its US sales moved up by 38.8 per cent to Rs. 1,897 crore and that in other markets increased by 8.4 per cent to Rs. 495 crore. EBITDA reached at Rs. 1,115 crore.

Cadila Healthcare has filed 29 ANDAs during 2018-19 with US FDA, taking the cumulative filings to 360. It received 74 ANDA approvals taking the total to 254 product approvals. Cadila entered into a collaborative research agreement with the Council of Scientific and Industrial Research (CSIR) – Institute of Micirobial Technology (IMTECH) to identify new drug candidates for the treatment of drug-resistant infections. Cadila also made preogress with its key research molecules, Disease (CKD) patients and Saroglitazar for the treatment of Non-Alcoholic SteatoHepatitis (NASH). The company acquired 51 per cent stake in Dehradun- based Windlas Healthcare Pvt Ltd.

SOURCE : Pharmabiz